Pladex is a prodrug. It inhibits platelet activation
and aggregation through the irreversible binding of its active metabolite to
the P2Y12 class of the ADP receptor on platelets. Dose-dependent inhibition of
platelet aggregation can be observed 2 hours after single oral doses. Repeated
doses of 75 mg daily inhibited ADP-induced platelet aggregation on day 1, and
inhibition reached steady-state from day 3 to day 7.
Acute Coronary Syndrome: In patients who need an
antiplatelet effect within hours, initiate clopidogrel with a single 300 mg (4
tablets) oral loading dose and then continue at 75 mg once daily. Initiating it
without a loading dose will delay the establishment of an antiplatelet effect
by several days.
Recent MI, Recent Stroke, or Established Peripheral
Arterial Disease: 75 mg once daily orally without a loading dose.
It is given orally with or without food.
- Non-steroidal anti-inflammatory drugs, warfarin, selective
serotonin, and serotonin norepinephrine reuptake inhibitors (SSRIs,
SNRIs): increase the risk of bleeding
- CYP2C19 inhibitors (omeprazole or esomeprazole) ): Avoid the
simultaneous use of omeprazole or esomeprazole
- Repaglinide (using CYP8C substrate at the same time)
clopidogrel and clopidogrel. Repaglinide, because it increases the plasma
concentration of Repaglinide
Pladex is contraindicated in the following situations:
Allergic to APIs or any component of the product. Active pathological bleeding,
such as a peptic ulcer or intracranial hemorrhage.
- Clopidogrel is a commonly tolerated drug.
- Common side effects: bleeding, diarrhea, gastrointestinal
discomfort, bleeding, skin reactions.
- Rare side effects: acquired hemophilia, anemia, angioedema,
arthralgia, arthritis, bone marrow disorders.
There are no adequate and well-controlled studies on
pregnant women. It should only be used during pregnancy when clearly needed. It
is not known whether Pladex is excreted in human milk. A decision should be
made to either discontinue breastfeeding or discontinue the drug, taking into
account the importance of the drug to the mother.
- Since it is a prodrug, the metabolism of its active
metabolites is affected by CYP2C19 (weak metabolizer) gene mutations and
drugs that inhibit CYP2C19 (such as omeprazole and esomeprazole).
Simultaneous use of these drugs and CYP2C19 weak metabolizers may reduce the
antiplatelet activity of clopidogrel.
- Because it inhibits platelet aggregation during the
entire life cycle (710 days) of platelets, it may increase the risk of
bleeding. In order to restore hemostasis, platelet transfusion within 4
hours after the loading dose or within 2 hours after the maintenance dose
may be less effective.
- Discontinuation of clopidogrel increases the risk of
cardiovascular events. If you stop 5 days before the elective surgery, you
have a higher risk of bleeding. Clopidogrel treatment was resumed
immediately after hemostasis.
- Thrombotic purpura (TTP) requires emergency treatment,
including plasma exchange (plasma exchange) has been reported.
- In patients receiving clopidogrel or patients with a
history of allergies to other thienopyridines, allergies have been
reported, including skin rash, angioedema, or hematological reactions.
Keep below 30°C temperature in a dry place.
Protected from light. Do not freeze. Keep out of the reach of children.